In an endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas

• US 5,354,295 A
• Filed: 02/24/1992
• Issued: 10/11/1994
• Est. Priority Date: 03/13/1990
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation), Regents of the University of California (University of California)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation), Regents of the University of California (University of California)
• Inventors: Sepetka, Ivan, Guglielmi, Guido
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/840,211
• Time in Patent Office: 960 Days
• Field of Search: 606/32, 606/41, 606/45, 606/28, 606/191, 606/108, 606/200, 128/772, 128/784, 128/786, 623/1, 623/12, 604/104
• US Class Current: 606/32
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61B 2018/1226 powered by a battery
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1266 with DC current output
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1495 Electrodes being detachable from a support structure
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular occlusion by the endovascular insertion of a platinum wire and/or tip into the vascular cavity. The vascular cavity is packed with the tip to obstruct blood flow or access of blood in the cavity such that the blood clots in the cavity and an occlusion if formed. The tip may be elongate and flexible so that it packs the cavity by being folded upon itself a multiple number of times, or may pack the cavity by virtue of a filamentary or fuzzy structure of the tip. The tip is then separated from the wire mechanically or by electrolytic separation of the tip from the wire. The wire and the microcatheter are thereafter removed leaving the tip embedded in the thrombus formed within the vascular cavity. Movement of wire in the microcatheter is more easily tracked by providing a radioopaque proximal marker on the microcatheter and a corresponding indicator marker on the wire. Electrothrombosis is facilitate by placing the ground electrode on the distal end of the microcatheter and flowing current between the microcatheter electrode and the tip.

Claims

1. A method for forming an occlusion within a vascular cavity having blood disposed therein comprising the steps of:

endovascularly disposing a relaxed coil wire near an endovascular opening into said vascular cavity, said relaxed coil wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape;

disposing a distal tip of said wire into said vascular cavity to substantially space fill said cavity to mechanically form said occlusion within said vascular cavity about said distal tip; and

nonthermally detaching said distal tip from said wire to leave said distal tip within said vascular cavity, wherein nonthermal detachment is defined as a detachment without substantially increasing the temperature of said distal tip and wire,

whereby said vascular cavity is occluded by said distal tip, and any thrombus formed by use of said tip.

2. The method of claim 1 wherein said step of detaching said digital tip from said wire without substantially increasing the temperature of said distal tip and wire comprises the step of mechanically detaching said distal tip from said wire.

3. The method of claim 1 where said wire and tip are used within a microcatheter and where in said step of nonthermally detaching said distal tip from said wire said wire and tip are longitudinally displaced within said microcatheter, said microcatheter having a radio-opaque proximal marker, said wire and tip having collectively a single radio-opaque marker, said displacement of said wire and tip moving said single radio-opaque marker to the proximity of said proximal marker on said microcatheter when said tip is fully deployed.

4. The method of claim 1 wherein said step of disposing said tip into said vascular cavity to substantially space fill said cavity comprises the step of disposing a tip having a plurality of filaments extending therefrom to pack said cavity.

5. The method of claim 1 wherein said step of disposing said tip into said vascular cavity to substantially space fill said cavity comprises the step of disposing a long flexible tip folded upon itself a multiple number of times to substantially space fill said cavity.

6. A method for forming an occlusion within a vascular cavity having blood disposed therein comprising the steps of:

endovascularly disposing a wire within a microcatheter near an endovascular opening into said vascular cavity, said microcatheter having a distal tip electrode;

disposing a distal tip of said wire into said vascular cavity to substantially space fill said cavity to form said occlusion within said vascular cavity about said distal tip by applying a current between an electrode on said distal end of said wire disposed into said cavity and said distal tip electrode on said microcatheter; and

nonthermally detaching said distal tip from said wire to leave said distal tip within said vascular cavity, wherein nonthermal detachment is defined as a detachment without substantially increasing the temperature of said distal tip and wire,

whereby said vascular cavity is occluded by said distal tip, and any thrombus formed by use of said tip.

7. A wire for use in formation of an occlusion within a vascular cavity used in combination with a microcatheter comprising:

a core wire having a distal portion; and

a detachable elongate tip portion extending said core wire for a predetermined lineal extent and adapted to being packed into said vascular cavity to form said occlusion in said vascular cavity and coupled to said distal portion of said core wire, said elongate tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape,

whereby endovascular occlusion of said vascular cavity can be performed.

8. The wire of claim 7 wherein said elongate tip portion is a long and substantially pliable segment adapted to be multiply folded upon itself to substantially space fill said vascular cavity.

9. The wire of claim 7 wherein said elongate tip portion is a segment adapted to be disposed in said vascular cavity and having a plurality of filaments extending therefrom to substantially space fill said vascular cavity when disposed therein.

10. The wire of claim 7 wherein said microcatheter has a pair of radioopaque markers disposed thereon and a distal end, and wherein said core wire has a radioopaque marker disposed thereon, said marker on said core wire being positioned in the proximity of one of said pair of markers on said microcatheter when said core wire is deployed, said other marker on said microcatheter indicating the distal end of said microcatheter.

11. The wire of claim 7 where said core wire and tip are coupled by polyester.

12. A microcatheter system for use in formation of an occlusion within a vascular cavity comprising:

a microcatheter having a distal end adapted for disposition in the proximity of said vascular cavity, said distal end having an electrode disposed thereon;

a conductive wire disposed in said microcatheter and longitudinally displaceable therein, said wire comprising;

a core wire having a distal portion; and

an elongate tip portion extending said core wire for a

predetermined lineal extent and adapted to being packed into said vascular cavity to form said occlusion in said vascular cavity and coupled to said distal portion of said core wire, said occlusion being formed by means of applying a current between said tip portion and said electrode on said microcatheter when said tip portion is disposed into said vascular cavity, said elongate tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape,

whereby endovascular occlusion of said vascular cavity can be performed.

13. An improvement in a method for forming an occlusion within a vascular cavity having blood disposed therein comprising the step of:

disposing a body into said vascular cavity without tending to induce any preferred geometric form for said vascular cavity by such disposition, said body being flexible, and shapeless, and having substantially no memory of its predisposed shape other than at most a relaxed, simple helical shape, said body being disposed into said vascular cavity to substantially impede movement of blood in said vascular cavity and to thereby form said occlusion within said vascular cavity,

whereby said vascular cavity is occluded by said body.

14. The method of claim 13 wherein said step of disposing said body in said vascular cavity comprises the step of packing said body to substantially obstruct said cavity.

15. The method of claim 14 where said step of packing said cavity with said body comprises the step of obstructing said cavity with a detachable elongate wire tip multiply folded upon itself in said cavity.

16. The method of claim 14 where said step of packing said cavity with said body comprises the step of obstructing said cavity with a body having a multiplicity of flexible filamentary shapes.

17. The method of claim 13 wherein said step of disposing said body into said vascular cavity comprises disposing in said vascular cavity means for slowing blood movement in said cavity to initiate formation of said occlusion in said cavity.

18. The method of claim 13 wherein the forming of said occlusion comprises the step of applying an electrical current to said body.

19. The method of claim 18 where said step of applying an electrical current to said body comprises the step of applying an electrical current between said body and a proximate electrode carried on a microcatheter used for disposing said body into said cavity.

20. The method of claim 13 wherein the forming of said occlusion comprises the step of mechanically forming said occlusion in said body.

21. The method of claim 13 wherein the forming of said occlusion comprises the step of applying an electrical current to said body and simultaneously mechanically forming said occlusion in said body.

22. A wire for use in formation of an occlusion within a vascular cavity used in combination with a microcatheter comprising:

a core wire having a distal portion;

a detachable elongate tip portion extending said core wire for a predetermined lineal extent adapted to being packed into said vascular cavity to form said occlusion in said vascular cavity and coupled to said distal portion of said core wire, said tip portion including a first flexible, shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first portion to said core wire, said second segment being adapted to be electrolysized upon application of current; and

an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof,

whereby endovascular occlusion of said vascular cavity can be performed.

23. A method for forming an occlusion within a vascular cavity having blood disposed therein comprising the steps of:

endovascularly disposing a wire near an endovascular opening into said vascular cavity;

disposing a distal tip of said wire into said vascular cavity to substantially space fill said cavity to form said occlusion within said vascular cavity about said distal tip;

forming an electrothrombosis in said vascular cavity by applying current through said distal tip; and

mechanically detaching said distal tip from said wire to leave said distal tip within said vascular cavity,

whereby said vascular cavity is occluded by said distal tip, and any thrombus formed by use of said tip.

24. A method for forming an occlusion within a vascular cavity having blood disposed therein comprising the steps of:

endovascularly disposing a wire within a microcatheter near an endovascular opening into said vascular cavity;

disposing a distal tip of said wire into said vascular cavity to substantially space fill said cavity to form said occlusion within said vascular cavity about said distal tip by applying a current to said distal tip packed into said cavity; and

mechanically detaching said distal tip from said wire to leave said distal tip within said vascular cavity,

whereby said vascular cavity is occluded by said distal tip, and any thrombus formed by use of said tip.